Posted by Michael Wonder on 12 Nov 2024
Nipocalimab is the first and only investigational therapy granted US FDA breakthrough therapy designation for the treatment of adults living with moderate to severe Sjögren’s disease
11 November 2024 - The breakthrough therapy designation for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study.
Johnson & Johnson today announced that the US FDA has granted nipocalimab breakthrough therapy designation for the treatment of adults living with moderate to severe Sjögren’s disease, a debilitating and chronic autoantibody disease with high prevalence, for which no approved advanced treatments are available.
